Meningitis outbreak: New drug compounding law proposed in Massachusetts

Jan. 5, 2013

Written by

Walter F. Roche Jr.

The Tennessean

In the wake of a fungal meningitis outbreak that has taken the lives of 14 Tennesseans, the governor of Massachusetts Friday proposed multiple changes in state laws and regulations governing compounding pharmacies, including the one blamed for the ongoing public health crisis.

Gov. Deval Patrick’s proposal, based in part on the recommendations of a special commission, would change the composition of the state board that licensed the New England Compounding Center and give the panel increased powers to regulate all compounding pharmacies located in Massachusetts or shipping drugs into Massachusetts from other states.

Under the proposal, compounding pharmacies such as New England Compounding would be required to get special licenses to handle sterile compounds like methylprednisolone acetate, the spinal steroid blamed for the current meningitis outbreak.

The bill would change the composition of the state Pharmacy Board, which is dominated by registered pharmacists, and provide for the appointment of a registered nurse, a physician, a pharmacy technician and three public members. It would make board members subject to financial disclosure requirements.

The Tennessee Pharmacy Board, which also is dominated by registered pharmacists, is scheduled to announce the results of its own investigation of the outbreak at meetings Jan. 16-17. NECC also held a license in Tennessee, but it has since been revoked, along with the one held by the firm’s chief pharmacist and part owner, Barry Cadden.

Asked whether Gov. Bill Haslam would be proposing any changes in Tennessee’s regulation of the compounding industry, spokesman Dave Smith wrote in an email, “There is an ongoing review through the state Department of Health with multiple stakeholders, including the Board of Pharmacy, to ensure the daily needs for medications of Tennesseans are met safely and reliably.”

Health Department spokesman Woody McMillin also cited the ongoing review and said the agency was involved in an ongoing “national conversation about measures to safeguard the public from contaminated medications.”

39 dead in U.S.

According to the latest data from the U.S. Centers for Disease Control and Prevention, fungus-tainted steroids from the Framingham, Mass., company have sickened 139 Tennesseans, most of whom received treatment at a Nashville clinic. Only Michigan has had more infections, with 232. Nationwide, 656 patients have been sickened and 39 have died. No cases have been reported in Massachusetts.

NECC filed for bankruptcy last month. A sister firm, Ameridose of Westborough, Mass., which also has been shut down, agreed Friday with state regulators to keep its plant shuttered until Feb. 22 because of a continuing investigation.

In announcing the package, Patrick conceded that no changes could eliminate all abuses, “but we must do what we can. The legislation makes patient safety paramount and will help fill the gaps in compounding pharmacy monitoring that allowed NECC to operate in the shadows.”

Other provisions of the package would increase funding for inspection staff and set new training requirements.

Patrick said he also would lend his support to another proposal amending the state’s criminal manslaughter statute to increase fines from $1,000 to $250,000 “to help deter and sufficiently punish corporations when they are found guilty of criminal wrongdoing.” A federal criminal investigation of NECC is ongoing.

Federal legislation also has been proposed to give the U.S. Food and Drug Administration clearer authority to regulate compounding drug companies that ship products across state lines.

Cleaner notified

In a related development, UniFirst Corp., a cleaning company with a contract with NECC, filed a disclosure statement with the U.S. Securities and Exchange Commission indicating that NECC is blaming UniFirst for the widespread sterility problems that led to the contamination of steroids.

UniFirst said in the filing that an attorney for NECC wrote a letter on Dec. 31 stating that UniFirst would have to pay for any awards stemming from pending lawsuits.

More than 50 lawsuits have been filed against NECC, including more than a dozen in Tennessee.

“If we are found to be liable,” UniFirst said in its filing, “with respect to claims brought against us relating to NECC that are not covered by our available insurance, we may incur liabilities that are material to our financial condition and operating results.”

The firm said in the filing that NECC’s demand “relates to the limited once-a-month cleaning services the company provided to portions of NECC’s cleanroom facilities.”

Patient files suit

Another lawsuit against the compounding firm was filed Friday in Davidson County Circuit Court. Virginia Neely, 86, of Nashville is seeking $4 million in compensatory damages. According to the complaint, Neely had to undergo surgery in December for a spinal infection caused by a spinal steroid supplied by NECC last summer.

“Defendant NECC offered and St. Thomas Outpatient Neurosurgical Center accepted and received a discount for purchasing methylprednisolone acetate through bulk shipments,” the complaint states.